Product Wiki · Recalls · Health Canada — Medical Devices

TC-I Reusable Tip Clip Sensors — recall 74240

Health Canada — Medical Devices · Canada · 2023-09-07 · Type II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →

Agency: Health Canada — Medical Devices
Recall identifier: 74240
Date of alert: 2023-09-07
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Anaesthesiology
Product type: Medical devices

Reported risk: Masimo identified TC-I Reusable Tip Clip Sensors with higher than expected variability in spO2 readings that are outside of the accuracy specification. Masimo's investigation found the TC-I sensors had higher variability with an overall arms of 4.4% compared to the specification of 3.5% arms. Recall Start Date: June 15, 2023

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/tc-reusable-tip-clip-sensors

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

TC-I Reusable Tip Clip Sensors — recall 74240

Related